Case Study: Melanoma, Left Upper Arm: 65 Year-Old Male*
- Pre-operative diagnosis
- Melanoma, Clark Level IV, posterior aspect of the L upper arm
- Tc 99m tilmanocept dosing
- 4 intradermal injections at 12, 3, 6, and 9 o’clock positions (4 TB syringes x .25mL per syringe)
- Total radioactive dose 0.50mCi
- Preoperative lymphoscintigraphy
- Planar images acquired for a total of 90-120 seconds each; three anterior and one lateral with and without Co-57 transmission source
- A single lymph node visualized in the mid L axilla within 15 minutes post injection
- Intra-operative findings: single sentinel lymph node identified within mid L axilla
- Node was pathology negative
Static Planar Images: Obtained for a total of 90-120 sec each
*Images and patient data provided courtesy of Nicholas Wickersham, MD and Elizabeth Beltran, CNMT, Boulder Community Health, Boulder, CO, USA
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
- Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
- Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.
In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).
Please see full Prescribing Information.
To report suspected adverse reactions, contact Navidea Biopharmaceuticals, Inc. at 1-800-476-5270 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch.